ATLAS - ATLAS

Description:

The goal of the ATLAS trial was to evaluate the safety and efficacy of the Liberte slow-release paclitaxel-eluting stent compared with historical control stent data among patients with single de novo coronary lesions.

Study Design

Patients Enrolled: 871
Mean Follow Up: 9 months

Primary Endpoints:

Target vessel revascularization at 9 months

Drug/Procedures Used:

Patients were treated with the Liberte slow-release paclitaxel-eluting stent (n=871). Repeat angiography was performed at 9 months. Data from patients enrolled in the trial were compared to matched historical control data from the TAXUS IV and TAXUS V trials.

Concomitant Medications:

Aspirin indefinitely and clopidogrel for at least six months.

Principal Findings:

Data were reported through 30 days; however, blinding was maintained as patient follow-up for the 9-month primary endpoint of target vessel revascularization is not yet completed. Results arbitrarily refer to groups X and Y to maintain blinding.

Major adverse cardiac events (MACE) occurred in 3.3% of group X and 2.8% of group Y. Among the MACE components, cardiac death was reported in 0.2% in each group, myocardial infarction in 3.0% of group X and 2.6% of group Y, and target vessel revascularization in 0.4% of group X and 0.2% of group Y. Stent thrombosis occurred in 0.5% of group X and 0.2% of group Y.

Interpretation:

Among patients with single de novo coronary lesions, the overall MACE rate was relatively low compared to other trials. However, data reported to date remain blinded, and conclusions regarding the efficacy of the new Liberte slow-release paclitaxel-eluting stent cannot be made.

References:

Presented by Dr. Mark Turco at the EuroPCR meeting, Paris, France, May 2005.

Turco MA, Ormiston JA, Popma JJ, et al. Polymer-based, paclitaxel-eluting TAXUS Liberté stent in de novo lesions: the pivotal TAXUS ATLAS trial. J Am Coll Cardiol. 2007 Apr 24;49(16):1676-83

Keywords: Paclitaxel, Coronary Artery Disease, Myocardial Infarction, Follow-Up Studies, Thrombosis, Drug-Eluting Stents


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